Ultrasound guided training simulators for cryoneurolysis pain blocks

ABSTRACT

In certain embodiments, the present disclosure provides an anthropomorphic phantom for use with cryoneurolysis training. The anthropomorphic phantom having a body shaped to simulate a human anatomical structure. In some forms, the phantom body comprises a first material configured to simulate human soft tissue, a simulated nerve embedded within the first material, and a simulated fascial plane embedded within the first material superficial to the simulated nerve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/852,122, filed May 23, 2019, which are hereby incorporated byreference.

BACKGROUND

Cryoneurolysis works by applying targeted cold to a peripheral sensorynerve, forming a precise ice ball under the skin at or near the targetnerve. This freezing of the nerve immediately prevents the nerve fromsending pain signals, and does not significantly damage surroundingpatient tissue structures. Thus, cryoanalgesia is a reversibleinhibition of the signal carrying part of the nerve. The effect on thenerve is temporary, and provides pain relief until the nerve regeneratesand function is restored.

In general, target nerves suitable for Cryoneurolysis are superficialand can be difficult to locate by traditional ultrasound techniques.Current ultrasound guided regional anesthesia simulators do not have thenecessary landmarks to train targeting superficial nerves with acryoneedle.

Previous Cryoneurolysis procedures were invasive, and used largecomplicated machines. In one example, a device having three needle tipswas utilized to achieve sufficient ice formation. These prior devicesare utilized to provide a field block, in conjunction with a traditionalregional anesthesia nerve block. These techniques are time consuming;requiring 30-40 minutes and can have irregular outcomes due to factorssuch as patient body mass index (BMI) and degree of overlap of needleplacement.

Prior ultrasound training simulation phantoms were designed only fortraditional nerve blocks. A need therefore exists for improvedCryoneurolysis procedures as well as methods and systems for trainingsuch procedures.

SUMMARY

The claims, and only the claims, recite the invention. In summary, itmay include devices and methods for training cryoneurolysis procedures.In certain embodiments, the present disclosure provides ananthropomorphic phantom having a body shaped to simulate a humananatomical structure, the phantom body comprising a first materialconfigured to simulate human soft tissue, a simulated nerve embeddedwithin the first material, and a simulated fascial plane embedded withinthe first material superficial to the simulated nerve. In some forms,the simulated fascial plane is distinctly imageable to from thesurrounding materials to simulate the sonographic characteristics ofhuman fascial planes and surrounding anatomy. In certain embodiments,the simulated fascial plane has a tensile strength greater than thefirst material. In some forms, the first material may further comprise ascattering agent embedded in the material to simulate the sonographiccharacteristics of human soft tissue. In some forms, the simulated nervemay further comprise a scattering agent embedded in the material tosimulate the sonographic characteristics of human nervous tissue.

In certain embodiments, the simulated nerve comprises a sensorconfigured to detect a signal from a cryoneurolysis training needle. Insome forms, the signal is a change in temperature caused by thecryoneurolysis training needle. In some forms, a system is providedwhich includes a controller responsive to the sensor and configured toindicate the status of the detected signal. In certain embodiments, thecontroller is electrically connected to the sensor.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is one example of a total knee anthropomorphic cryoneurolysistraining phantom.

FIG. 2 is a cross-sectional view of one example of an anthropomorphiccryoneurolysis training phantom.

FIG. 3 is one example of an anthropomorphic cryoneurolysis trainingphantom.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationsin the described embodiments, and any further applications of theprinciples of the invention as described herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates. One embodiment of the invention is shown in great detail;although it will be apparent to those skilled in the relevant art thatsome features that are not relevant to the present invention may not beshown for the sake of clarity.

As used here (claims, specification, and other definitions) thefollowing terms have the following meaning:

Articles and phases such as, “the”, “a”, “an”, “at least one”, and “afirst”, “comprising”, “having” and “including” here are not limited tomean only one, but rather are inclusive and open ended to also include,optionally, two or more of such elements and/or other elements. In termsof the meaning of words or terms or phrases herein, literal differencestherein are not superfluous and have different meaning, and are not tobe synonymous with words or terms or phrases in the same or otherclaims.

The term “means for” in a claim invokes 35 U.S.C. § 112(f), literallyencompassing the recited function and corresponding structure andequivalents thereto. Its absence does not, unless there otherwise isinsufficient structure recited for that claim element. Nothing herein orelsewhere restricts the doctrine of equivalents available to thepatentee.

The term “and/or” is inclusive here, meaning “and” as well as “or”. Forexample, “P and/or Q” encompasses, P, Q, and P with Q; and, such “Pand/or Q” may include other elements as well.

The term “anesthetizing” as used herein has the meaning, a process forproviding temporary loss of sensation, muscle control, and/or awareness.

The term “anterior” as used herein has the meaning, being situatednearest or toward the front of the body. With respect to the spine, theanterior is considered to be the side of the spine closest to thestomach or the throat.

The term “anteriorly” as used herein has the meaning, positioned in alocation more anterior with respect to another object where the anteriorrefers to a position nearer to the front of a reference point.

The term “body portion” as used herein has the meaning, the main orprincipal part of an object. More specifically, it refers to the part ofa vertebra implant that contacts the vertebral body of a neighboringvertebra.

The term “contact” as used herein has the meaning, of two objects thestate or condition of physical touching. As used, contact requires atleast one location where objects are directly or indirectly touching,with or without any other member(s) material in between.

The term “cranial-caudal orientation” as used herein has the meaning, inthe direction along an axis running vertically toward and away from a(standing) patient's skull.

The term “cranial direction” as used herein has the meaning, in thedirection toward the patient's head along the cranial-caudal axis.

The term “caudal direction” as used herein has the meaning, in thedirection towards the patient's feet along the cranial-caudal axis.

The term “cryoanalgesia” (also known as cryoneurolysis) as used hereinhas the meaning is the reversible destruction of the signal carryingparts of a nerve. It is a small subset of treatments under the broadumbrella of cryotherapy.

The term “cryo-needle” as used herein has the meaning, a medical devicehaving a slender, usually sharp pointed body and configured to causefreezing at the distal end, (which may include its tip, but also may beportions near to but proximal to the tip), upon activation.

The term “discectomy” as used herein has the meaning, a surgical removalof all or part of an intervertebral disc.

The term “dorsal ramus” as used herein has the meaning, the posteriordivision of a spinal nerve that forms the dorsal root of the nerve as itemerges from the spinal cord.

The term “Erector Spinae Plane Block” as used herein has the meaning, aparaspinal fascial plane block that involves injection of localanesthetic between the erector spinae muscle and the transverse process,thus blocking inhibiting the dorsal and/or ventral rami of the spinalnerve. Upon injection the local anesthetic spreads in a cranial and/orcaudal direction inhibiting the dorsal and or ventral rami ofneighboring spinal nerves along the spinal cord.

The term “facilitate” as used herein has the meaning, to aid or helpaccomplish an action or a process to make that action or process easier.The act of facilitation does not need to accomplish the action orprocess entirely on its own.

The term “front surface” as used herein has the meaning, an exteriorsurface which may or may not be the anterior most surface.

The term “hole” as used herein has the meaning, a hollow opening withina body, structure, or an object. It can be any shape.

The term “imageable” as used herein has the meaning, a device which isconfigured to allow for medical imaging of the device during use such asby computed tomography (CT), magnetic resonance (MRI), positron emissiontomography (PET), fluoroscopy, and/or ultrasonography. As used hereinthe “imageable” device is configured to allow a user to visualize all ora portion of the device within the patient during a procedure.

The term “laminectomy” as used herein has the meaning, a surgicaloperation to remove the back of one or more vertebrae, usually to giveaccess to the spinal cord or to relieve pressure on nerves.

The term “pain block” as used herein has the meaning, inhibition of oneor more sensory nerves that relay pain signals to a target region of thepatient's body.

The term “local anesthesia” as used herein has the meaning, a medicationthat causes reversible absence of pain sensation in a target area of thebody. When it is used on specific nerve pathways, paralysis also can beachieved.

The term “sensory nerve” as used herein has the meaning, a nerve thatcarries sensory information toward the central nervous system (CNS).

The term “side” as used herein has the meaning, one of the faces on thesurface of an object. An object can have multiple faces with a varietyof orientations. For example, an object may have a front side, a bottomside, a back side, or a top side.

The term “spinal fusion” as used herein has the meaning, a neurosurgicalor orthopedic surgical technique that joins two or more vertebrae. Thisprocedure can be performed at any level in the spine and prevents anymovement between the fused vertebrae. Spinal fusion may also be calledspondylodesis or spondylosyndesis.

The term “spinal surgery” as used herein has the meaning, any surgicalprocedure including the patient's spinal cord.

The term “superficial” as used herein has the meaning, a directionalterm that indicated one structure is located more externally thananother, or closer to the surface of the body.

The term “transverse” as used herein has the meaning, situated orextending across an object or an axis.

The term “vertebra” as used herein has the meaning, a bone or objectthat forms part of the spinal column. The vertebra could be composed ofbone or it can be an implant formed from any variety of materials thatwould be useful to replace bone such as titanium, stainless steel, orother metallic or non-metallic compounds.

The term “withdrawal” as used herein has the meaning, the action ofremoving or taking away something for a particular location.

Until now, traditional cryotherapy treatments were invasive, and usedlarge complicated machines. A new generation of cryo-needles hasrevolutionized the delivery of cryoanalgesia. One example is the Ioverasystem by Myoscience.

With cryo-needle systems, doctors are able to deliver precise,controlled doses of cold temperature only to the targeted nerve througha handheld device. This needle-based procedure is safe, and does notdamage or destroy the surrounding tissue.

These cryo-needle based treatments use the body's natural response tocold to treat peripheral nerves and immediately reduce pain—without theuse of drugs. Treated nerves are temporarily stopped from sending painsignals for a period of time, followed by a restoration of function.

Cryo-needle therapies work by applying targeted cold to a peripheralnerve. A precise cold zone is formed under the skin—cold enough toimmediately prevent the nerve from sending pain signals without causingdamage to surrounding structures. The effect on the nerve is temporary,providing pain relief until the nerve regenerates and function isrestored.

Cryo-needle therapies generally do not require further injection of anysubstance such as drugs, opioids or narcotics. The effect of thistreatment is immediate and can last weeks to several months depending onthe multiple factors, including the patients anatomy and pain tolerance.In one study, a majority of the patients suffering from osteoarthritisof the knee have experienced pain and symptom relief beyond 150 days.”See also, Radnovich, R. et al. “Cryoneurolysis to treat the pain andsymptoms of knee osteoarthritis: a multicenter, randomized,double-blind, sham-controlled trial.” Osteoarthritis and Cartilage(2017) p1-10. (incorporated herein by reference) Cryo-needle therapiesuse FDA (Food and Drug Administration) approved devices having needleswith distal ends that create ice balls, allowing targeted nerves to bestunned inhibiting transmission of pain signals. The procedure iscompletely reversible weeks to months later.

Cryo-needle therapy technology has allowed tremendous pain control fororthopedic procedures such as total knee and total hip replacement.Freezing the sensory skin nerves of the anterior thigh for total kneereplacement and the lateral thigh for hip replacement has resulted insignificant drops in opioid need and postoperative pain scores. Similarresults are available for sensory freezing the posterior cutaneousnerves of the spine. Freezing cutaneous nerves alone may not providesufficient pain relief. We have supplemented the cryoanalgesia treatmentwith a nerve block called an Erector Spinae Block. Erector spinae blocksare generally placed by physicians, for example anesthesiologists, usingultrasound. Erector spinae blocks may also be placed by surgeons usingguided navigation surgery software. Using cryo-needle technology forpreviously untried lumbar fusion spine procedures provides surprisingsuccess. Other possible applications include anesthesia pain blocks forchronic pain, thus avoiding more invasive epidural steroid injections.Routine lumbar discectomy and laminectomy patients may also receivecryo-needle treatment at the end of surgeries. More complex cervical andthoracic spine applications are also possible.

Sensory nerves that are targeted for pain relief may innervate anterior,posterior, and/or lateral regions of the body. In certain embodiments,the current disclosure provides methods of training for anesthetizing apatient undergoing surgical procedures at or in anterior, posterior,and/or lateral regions of the body.

The lateral region of the body includes lateral portions of the thoraxas well as extremities, hips, knees, arms, elbows, shoulders, hands,feet, and legs.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom configured to simulate one or more structuresand/or regions of a human body. In some forms an anthropomorphic phantomof the present disclosure is configured to simulate: skin, muscle,nerves, bones, chest wall, breast, esophagus, trachea, lungs, pleura,diaphragm, mediastinum, heart, pericardium, great vessels with andwithout pump oxygenator, anterior cervical spine, anterior thoracicspine, anterior lumbar spine, upper anterior abdominal wall includinghernias (lumbar, ventral, umbilical, incisional, diaphragmatic,omphalocele), anterior major abdominal blood vessels, spleen, liver,pancreas, liver, anterior lower abdomen wall (hernias), kidney uterus,bladder, adrenal glands, prostate, vagina, and/or anterior pelvis.Surgical procedures which may be performed in conjunction with theanterior region of the body in accordance with the present disclosureinclude, for example: thoracoscopy, thoracotomy, transplant, anteriorintraperitoneal procedures such as spleen, liver, pancreas, livertransplant, and/or gastric bypass, abdominoperineal resection,hysterectomy, pelvic exenteration, nephrectomy, adrenalectomy, renaltransplant, prostatectomy, and/or vaginal procedures.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom configured to simulate one or more structuresand/or regions of a human body. In some forms an anthropomorphic phantomof the present disclosure is configured to simulate: cervical spine,thoracic spine, lumbar spine, sacral spine, extensive complex spine,and/or spinal cord instrumentation cervical spine to sacral spine

In certain embodiments, the cryo-needle comprises two or more needleends configured to cool surrounding patient tissue. In some forms, thetwo or more needle ends are configured in a generally linear array.

In accordance some forms of practicing the disclosed methods, animageable cryo-needle is used, such that the erector spinae block and/orthe cryo-needle are placed using guidance from a medical imaging device.Alternatively, or in combination with the above, guided surgicalnavigation software has developed and evolved over the past two decades.For example, the Stealth surgical navigation system by Medtronic. Today,surgeons (e.g. neurosurgeon or orthopedic spine surgeon) rely on propersoftware for complex spine procedures. Evolution of surgical practicehas led to innovations like CT/MRI guided fusions, passive markers,touch screen displays and laser surface registration. Postoperativemultimodal pain pathways have been marginal at best for controllingsevere pain associated with these complex spine procedures. Regionalanesthesia pain blocks have not been commonly practiced with spinesurgery for multiple reasons. For example, guided navigation requiressensory monitoring of spinal cord signals throughout the procedure.Local anesthetics would, or may, prevent or impede sensory monitoring.Thus, preoperative pain blocks using conventional local anestheticsbefore surgery is not normally possible. In addition, reducingpostoperative pain with local anesthetic pain blocks may maskinadvertent surgical epidural hematoma.

In some forms, the present disclosure provides for anthropomorphicphantoms having the look and feel of human tissue during a cryo-needletherapy and related procedures as disclosed herein. Anthropomorphicphantoms as used herein may comprise all or part of a simulated patient.For example, in some forms the present disclosure provides foranthropomorphic phantoms configured to simulate one or more anatomicalstructures of a mammal, preferably a human. A full torso ultrasoundsimulator model 300 is seen in FIG. 3 . In some forms larger models,such as the full torso model shown in FIG. 3 , have the ability to bepartitioned into smaller subunits. Such module designs are advantageouswhen, for example, certain facilities may only desire a portion of themodel, such as the abdomen, thorax, spine, and/or lower extremities.

Current simulator models are ultrasound compatible for traditionalregional anesthesia nerve blocks and may be configured to usecommercially available needles and local anesthetic solutions fortraining. Traditional regional anesthesia nerve blocks targetcompartments and relatively large volumes of local anesthetic flood theintended site. Cryoneurolysis needles on the other hand, are dull andrequire an introducer port opening created by a sharp needle. Targetnerves for cryoneurolysis tend to be smaller and more superficial to thesurface than those targeted by traditional anesthesia nerve blocks.Thus, precise ultrasound skill is required to place the dullcryoneurolysis needle between fascial planes adjacent to the targetnerve. This in one example a sharp needle having a peel-away sheath isused to access through an outer layer.

In certain embodiments, the present disclosure provides a method ofusing an anthropomorphic phantom, the method comprising the steps ofvisualizing a target nerve, introducing a first needle through an outerlayer to reach the target nerve, removing the first needle, andintroducing a second needle to the target nerve. In certain embodiments,the visualizing comprises ultrasound visualization. In certainembodiments the introducing the first needle comprises piercing the skinof a patient or the simulated skin of an anthropomorphic phantom. Incertain embodiments, the first needle comprises a peel-away sheath,which allows for access of the second needle to the target nerve. Inpreferred embodiments, the second needle comprises a cryoneurolysisneedle. In some forms, the second needle (e.g. cryoneurolysis needle) isadvanced further into the patient tissue to reach the target nerve. Incertain embodiments, the method further comprises activating thecryoneurolysis needle to cause cooling of the target nerve.

Anthropomorphic phantoms of the present disclosure are configured tosimulate anatomical tissues. In certain embodiments, the anthropomorphicphantom of the present disclosure comprises one or more materialsconfigured to simulate one or more soft tissues such as skin, fascia,vasculature, nerve, muscle, and or adipose tissues. In certainembodiments, such materials are configured to mimic the tactileproperties of natural tissues, including puncture resistance. In someforms, such materials are configured to mimic the tensile strengthcharacteristics of natural tissue. In some forms, such materials areconfigured to mimic the imageable characteristics of natural tissues tosimulate sonographic characteristics of natural tissues. In this way,the anthropomorphic phantom may comprise one or more thermoplasticelastomers. Exemplary thermoplastic elastomers include highlyplasticized styrene, ethylene, butylene, and/or styrene blockcopolymers. In this way, anthropomorphic phantoms of the presentdisclosure may be formed by heating and/or mixing one or more chemicalcompositions and pouring the heated composition into a mold to form asimulated anatomical structure. For example, in some formsanthropomorphic phantoms of the present disclosure may be formed byheating and/or mixing one or more thermoplastic elastomers and pouringthe heated composition into a mold to form a simulated anatomicalstructure. In certain embodiments, various pigments may also be added tothe material to differentiate tissue structure and/or simulate naturaltissue. In certain embodiments, one or more scattering agents are addedto the thermoplastic compositions. The scattering agent(s) is selectedto confer natural sonographic characteristics to the anthropomorphicphantom. Examples of scattering agents include talcum powder, graphitepowder, and/or glass spheres.

In some forms, the anthropomorphic phantom of the present disclosure maycomprise a simulated fascial plane. In certain embodiments, thesimulated fascial plane is associated with one or more other materialssimulating structures superficial and/or deep to the simulated fascialplane. In some forms, the simulated fascial plane has a tensile strengthgreater than one or more surrounding materials. This allows for tactilefeedback to a user when penetrating the anthropomorphic phantom so as toindicate arrival of the instrument at or through the fascial plane.

In certain embodiments, the anthropomorphic phantom of the presentdisclosure includes one or more simulated nerves. In some forms, thesimulated nerve(s) is embedded in one or more other materials simulatingtissue structures surrounding the simulated nerve. In accordance withcertain inventive variants, the simulated nerve comprises a sensorconfigured to detect a signal from a Cryoneurolysis training needed. Incertain embodiments, the simulated nerve is configured to detect achange in temperature, for example the presence of an ice ball formed bya cryo-needle sufficiently near the simulated nerve so as to inhibit anatural nerve. In this way, anthropomorphic phantoms provided by thepresent disclosure may further comprise a controller responsive to thesimulated nerve sensor and configured to indicate a status of thedetected signal. For example in certain embodiments, an audible orvisible signal is produced upon activation of the sensor signifyingsufficient inhibition of the nerve. In certain embodiments, thecontroller is electrically connected to the sensor. In some forms, thesensor is configured to detect the duration of the signal.

In certain embodiments the cryoneurolysis training device of the presentdisclosure comprises a hand piece having a training cryoneurolysisneedle attached thereto, the hand piece operably connected to a displaysuch as a monitor. The hand piece is configured to send a signal to thedisplay when the phantom target structure is contacted by the trainingcryoneurolysis needle. Thus in certain embodiments, the display isconfigured to present a signal to confirm the paresthesia experiencedduring cryoneurolysis on living patients. In some forms, the positivesignal persists while the target nerve is actively cooled, thus a targetduration of treatment can be simulated. In certain embodiments, thetarget nerve is cooled for at least thirty seconds, preferably at leastforty-five seconds, even more preferably at least sixty seconds.

In accordance with certain inventive variants, the present disclosureprovides for an anthropomorphic phantom for use with cryoneurolysisprocedure training for surgical procedures in and around the knee joint.Exemplary procedures with which the anthropomorphic phantom of thepresent disclosure may be used include but are not limited to: kneereplacement (e.g. knee arthroplasty, or total knee replacement), partialknee replacement, patella replacement or repair, complex kneereplacement, removal or repair of meniscus, anterior cruciate ligament(ACL) surgery, removal or repair of synovial tissues, removal or repairof damaged articular cartilage, removal of loose bone fragments of boneor cartilage, and/or treatment of sepsis in or around the knee joint.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor total knee arthroplasty. With reference to FIG. 1 , in certainembodiments, the present disclosure provides an anthropomorphic phantom100 configured to simulate a human knee. In accordance with some forms,an anthropomorphic phantom may comprise one or more simulated bones, forexample a simulated femur 102, a simulated tibia 104, and/or a simulatedfibula 106. In certain embodiments, an anthropomorphic phantom mayinclude a simulated patella. In the illustrated embodiment, thesimulated bones are partial bone segments configured to allow trainingon the knee joint. It is within the scope of the disclosure to provideanthropomorphic cryoneurolysis training phantoms having completesimulated bone structures as well. In accordance with some forms, ananthropomorphic phantom may comprise one or more simulated nerves, forexample a simulated medial femoral cutaneous nerve 110, a simulatedintermediate femoral cutaneous nerve 112, a simulated lateral femoralcutaneous nerve 114, a simulated infra patellar branch of the saphenousnerve 116, a simulated common peroneal nerve 118, a simulated posteriorfemoral cutaneous nerve, a simulated obturator nerve, a simulated tibialnerve, and/or a simulated nerve to the vastus medialis. As discussedherein, anthropomorphic cryoneurolysis training phantoms of the presentdisclosure may also include simulated soft tissue structures associatedwith the simulated bone and/or nerve structures. For example, in certainembodiments an anthropomorphic cryoneurolysis training phantom mayinclude a knee joint comprising: simulated ligaments, simulated muscletissue, simulated fascial tissue, simulated adipose tissue, simulatedcartilage, simulated vasculature, and/or simulated dermal tissue. Asdiscussed herein these simulated soft tissue may be configured to appearnatural under ultrasound guidance and to provide natural physicalfeedback to the user. Thus in certain embodiments the present disclosureprovides materials and methods for anesthesia training of a total kneearthroplasty including percutaneously accessing one or more of thelisted structures with a cryoneurolysis needle. In certain embodiments,cryoneurolysis is applied once the target structure (e.g. nerve) isaccessed.

FIG. 2 is a cross-sectional view of one example of an anthropomorphiccryoneurolysis training phantom 200. The anthropomorphic cryoneurolysistraining phantom of the illustrated embodiment contains simulatedfeatures useful, for example, for training cryoneurolysis for a totalknee procedure including the femoral triangle 240. Certain embodimentsinclude simulated connective tissues, for example, the fibrous roof 242of the femoral triangle. In certain embodiments, anthropomorphiccryoneurolysis training phantoms may include simulated bone structures.Simulated structures of the illustrated embodiment include simulatedfemur 202. In certain embodiments, anthropomorphic cryoneurolysistraining phantoms may include simulated muscle tissue. For example, theillustrated embodiment comprises a simulated adductor longus 210, asimulated vastus medialis 212, and a simulated Sartorius 214. In certainembodiments, anthropomorphic cryoneurolysis training phantoms mayinclude simulated vasculature. For example, the illustrated embodimentcomprises simulated vessels of the profunda femoris 220, a simulatedfemoral artery 222, and a simulated femoral vein 224. In certainembodiments, anthropomorphic cryoneurolysis training phantoms mayinclude simulated nerves. For example, the illustrated embodimentcomprises a simulated saphenous nerve to the vastus medialis 230, andsimulated nerves of the subsartorial plexus 232.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor posterior knee. In certain embodiments, the anthropomorphic phantomdescribed herein includes the medial knee epicondyle. Thus in certainembodiments the present disclosure provides materials and methods foranesthesia training of a posterior knee procedure includingpercutaneously accessing the medial knee epicondyle with acryoneurolysis needle. In certain embodiments, cryoneurolysis is appliedonce the target structure (e.g. nerve) is accessed.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor total hip arthroplasty. In certain embodiments, the anthropomorphicphantom described herein includes the lateral femoral cutaneous nerve.Thus in certain embodiments the present disclosure provides materialsand methods for anesthesia training of a total hip arthroplastyincluding percutaneously accessing the lateral femoral cutaneous nervewith a cryoneurolysis needle. In certain embodiments, cryoneurolysis isapplied once the target structure (e.g. nerve) is accessed.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor shoulder surgery. In certain embodiments, the anthropomorphicphantom described herein includes the supra scapular nerve. Thus incertain embodiments the present disclosure provides materials andmethods for anesthesia training of a shoulder surgery includingpercutaneously accessing the lateral supra scapular nerve with acryoneurolysis needle. In certain embodiments, cryoneurolysis is appliedonce the target structure (e.g. nerve) is accessed.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor spinal surgery, in particular for erector spinea blocks. In certainembodiments, the anthropomorphic phantom described herein includes thespinal nerve, including the medial dorsal rami. Thus in certainembodiments the present disclosure provides materials and methods foranesthesia training of a spinal surgery including percutaneouslyaccessing the dorsal rami with a cryoneurolysis needle. In certainembodiments, cryoneurolysis is applied once the target structure (e.g.nerve) is accessed.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor an ankle block. In certain embodiments, the anthropomorphic phantomdescribed herein includes one or more of the following structures:peroneal nerve, posterior tibial nerve, sural nerve, and/or saphenousnerve. Thus in certain embodiments the present disclosure providesmaterials and methods for anesthesia training of an ankle blockincluding percutaneously accessing one or more of the listed structureswith a cryoneurolysis needle. In certain embodiments, cryoneurolysis isapplied once the target structure (e.g. nerve) is accessed.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor abdominal surgery, in particular an abdomen-tap block, transversalisfascia block, and/or ilioinguinal nerve block. Thus in certainembodiments the present disclosure provides materials and methods foranesthesia training of an abdominal surgery including percutaneouslyaccessing the target nerve with a cryoneurolysis needle. In certainembodiments, cryoneurolysis is applied once the target structure (e.g.nerve) is accessed.

In certain embodiments, the present disclosure provides for ananthropomorphic phantom for use with cryoneurolysis procedure trainingfor surgeries of the anterior and posterior chest wall, including breastsurgery, thoracotomy, cardiac surgery, and/or upper abdominal surgery.Thus in certain embodiments the present disclosure provides materialsand methods for anesthesia training of an abdominal surgery includingpercutaneously accessing the target structure (e.g. serrates anterior,and/or intercostal nerves) with a cryoneurolysis needle. In certainembodiments, cryoneurolysis is applied once the target structure (e.g.nerve) is accessed.

Listing of Certain Embodiments

The following provides an enumerated listing of some of the embodimentsdisclosed herein. It will be understood that this listing isnon-limiting, and that individual features or combinations of features(e.g. 2, 3 or 4 features) as described in the Detailed Description abovecan be incorporated with the below-listed Embodiments to provideadditional disclosed embodiments herein.

-   1. An anthropomorphic phantom for use with cryoneurolysis procedure    training, comprising:

a phantom body shaped to simulate a human anatomical structure, thephantom body comprising a first material configured to simulate humansoft tissue;

a simulated nerve embedded within the first material; and

a simulated fascial plane embedded within the first material superficialto said simulated nerve, the simulated fascial plane being distinctlyimageable to simulate sonographic characteristics of human fascialplanes.

-   2. The anthropomorphic phantom of embodiment 1, wherein said    simulated fascial plane has a tensile strength greater than said    first material.-   3. The anthropomorphic phantom of any one of the preceding    embodiments, wherein said first material comprises a chemical    composition capable of being heated and poured into a mold to form a    simulated anatomical structure.-   4. The anthropomorphic phantom of embodiment 3, wherein said    chemical composition comprises thermoplastic elastomers that are    heated, mixed together and then poured into said mold.-   5. The anthropomorphic phantom of embodiment 4, further comprising a    pigment mixed with said thermoplastic elastomers.-   6. The anthropomorphic phantom of any one of the preceding    embodiments, further comprising at least one scattering agent    embedded in the first material to simulate sonographic    characteristics of a human soft tissue.-   7. The anthropomorphic phantom of any one of the preceding    embodiments, further comprising at least one scattering agent    embedded in the simulated nerve to simulate sonographic    characteristics of a human nerve.-   8. The anthropomorphic phantom of any one of the preceding    embodiments, wherein the simulated nerve comprises a sensor    configured to detect a signal from a cryoneurolysis training needle.-   9. The anthropomorphic phantom of embodiment 8 wherein the signal    comprises a change in temperature caused by the cryoneurolysis    training needle.-   10. The anthropomorphic phantom of any one of embodiments 8 or 9,    further comprising a controller responsive to said sensor, the    controller configured to indicate a status of the detected signal.-   11. The anthropomorphic phantom of embodiment 10, wherein said    controller is electrically connected to said sensor.-   12. The anthropomorphic phantom of any one of embodiments 8 through    11, wherein said sensor is configured to detect a duration of the    signal.-   13. The anthropomorphic phantom of any one of the preceding    embodiments, wherein said phantom body is shaped to simulate a human    knee.-   14. The anthropomorphic phantom of any one of the preceding    embodiments, wherein said phantom body is shaped to simulate a human    thorax.-   15. A method of using an anthropomorphic phantom for cryoneurolysis    training, the method comprising the steps of:

visualizing a target nerve; and

introducing an introducer needle through an outer layer of theanthropomorphic phantom to reach the target nerve, wherein theintroducer needle provides an access path to the target nerve; and

introducing a cryoneurolysis needle through the access path to thetarget nerve.

-   16. The method of embodiment 15, further comprising:

activating the cryoneurolysis needle to cause cooling of the targetnerve.

-   17. The method of any one of embodiments 15 to 16, wherein said    visualizing comprises ultrasound visualization.-   18. The method of any one of embodiments 15 to 17, wherein said    introducer needle comprises a peel away sheath.

The invention may include any one or more articles or devices made byany of the claimed methods and/or may by different methods but with aclaimed composition.

The language used in the claims and the written description and in theabove definitions is to only have its plain and ordinary meaning, exceptfor terms explicitly defined above. Such plain and ordinary meaning isdefined here as inclusive of all consistent dictionary definitions fromthe most recently published (on the filing date of this document)general purpose Webster's dictionaries and Random House dictionaries.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges, equivalents, and modifications that come within the spirit ofthe inventions defined by following claims are desired to be protected.All publications, patents, and patent applications cited in thisspecification are herein incorporated by reference as if each individualpublication, patent, or patent application were specifically andindividually indicated to be incorporated by reference and set forth inits entirety herein.

The invention claimed is:
 1. An anthropomorphic phantom for use withcryoneurolysis procedure training, comprising: a phantom body shaped tosimulate a human anatomical structure, the phantom body comprising afirst material configured to simulate human soft tissue; a simulatednerve embedded within the first material, wherein the simulated nervecomprises a sensor configured to detect a signal from a cryoneurolysistraining needle, and wherein the signal comprises a change intemperature caused by the cryoneurolysis training needle; and asimulated fascial plane embedded within the first material superficialto said simulated nerve, the simulated fascial plane being distinctlyimageable to simulate sonographic characteristics of human fascialplanes.
 2. The anthropomorphic phantom of claim 1, wherein saidsimulated fascial plane has a tensile strength greater than said firstmaterial.
 3. The anthropomorphic phantom of claim 1, wherein said firstmaterial comprises a chemical composition capable of being heated andpoured into a mold to form a simulated anatomical structure.
 4. Theanthropomorphic phantom of claim 3, wherein said chemical compositioncomprises thermoplastic elastomers that are heated, mixed together andthen poured into said mold.
 5. The anthropomorphic phantom of claim 4,further comprising a pigment mixed with said thermoplastic elastomers.6. The anthropomorphic phantom of claim 1, further comprising at leastone scattering agent embedded in the first material to simulatesonographic characteristics of a human soft tissue.
 7. Theanthropomorphic phantom of claim 1, further comprising at least onescattering agent embedded in the simulated nerve to simulate sonographiccharacteristics of a human nerve.
 8. The anthropomorphic phantom ofclaim 1, further comprising a controller responsive to said sensor, thecontroller configured to indicate a status of the detected signal. 9.The anthropomorphic phantom of claim 8, wherein said controller iselectrically connected to said sensor.
 10. The anthropomorphic phantomof claim 1, wherein said sensor is configured to detect a duration ofthe signal.
 11. The anthropomorphic phantom of claim 1, wherein saidphantom body is shaped to simulate a human knee.
 12. The anthropomorphicphantom of claim 1, wherein said phantom body is shaped to simulate ahuman thorax.
 13. A method of using an anthropomorphic phantom forcryoneurolysis training, the method comprising the steps of: visualizinga target nerve; and introducing an introducer needle through an outerlayer of the anthropomorphic phantom to reach the target nerve, whereinthe introducer needle provides an access path to the target nerve; andintroducing a cryoneurolysis needle through the access path to thetarget nerve.
 14. The method of claim 13, further comprising: activatingthe cryoneurolysis needle to cause cooling of the target nerve.
 15. Themethod of claim 13, wherein said visualizing comprises ultrasoundvisualization.
 16. The method of claim 13, wherein said introducerneedle comprises a peel away sheath.